Gibbons Law Alert

Gibbons Law Alert Blog

On March 11, 2010

A bill introduced on March 8, 2010, by Assemblyman John J. Burchizelli, and voted out of the Assembly Regulatory Oversight and Gaming Committee would prohibit all State agencies from adopting — or even proposing — regulatory standards tighter than those imposed by the federal government, unless such action is specifically authorized by State law. The measure, Assembly Bill No. 2486, would greatly affect environmental regulation, where federal law often sets nationally applicable requirements, but does not preempt State requirements that go beyond the federal “floor.” The bill does not define the key term “specifically authorized by State law.” It would not apply to regulations in effect on the date of its enactment, or to the readoption of such regulations in the future.

Reed Elsevier v. Muchnick: Copyright Registration is Not a Jurisdictional Requirement

by Gibbons P.C.

Posted in Copyright

On March 10, 2010

Last week, the Supreme Court issued its highly-anticipated decision in Reed Elsevier v. Muchnick. The decision arose out of a class action settlement between publishers and authors following the Supreme Court’s holding affirming copyright infringement in New York Times, Co. v. Tasini. The Southern District of New York certified the settlement, but the Second Circuit reversed, holding that pursuant to §411(a) of the Copyright Act, the Court lacked subject-matter jurisdiction to approve the settlement because the settlement covered both registered and unregistered works. The Supreme Court reversed, holding that the registration requirement of §411(a) was a claim processing rule and not a jurisdictional requirement. It left open, however, the question of how strictly §411(a) should be applied.

New York City Increases Penalties for Illegal Dumping

by Gibbons P.C.

Posted in Environmental and Green Issues

On March 10, 2010

On March 3 the City Council of New York approved legislation designed to deter illegal dumping into the city’s waterways. The measure increases the maximum penalty for illegally dumping such materials as dirt, sludge, acid, or any other “refuse matters” from $250 to $10,000 for a first violation and $20,000 for subsequent violations.

How Dirty Is Dirty? Court of Appeals Says Even Minimally Contaminated Sites Can Qualify for New York Redevelopment Incentives

by Gibbons P.C.

Posted in Development/Redevelopment / Environmental and Green Issues

On March 9, 2010

The tables were turned in a case decided by the New York Court of Appeals on February 18. In a reversal of their usual roles, an upstate developer argued that its properties were contaminated, while the Department of Environmental Conservation (DEC) argued that the sites did not require remediation. The court agreed with the developer, and the result could mean significant tax credits for potential redevelopers of contaminated sites throughout the state.

Construction Projects and Compliance with New Stormwater Rules

by John H. Klock

Posted in Environmental and Green Issues

On March 9, 2010

On February 1, 2010 all construction projects that are over one acre in size must comply with the United States Environmental Protection Agency rules that were published on December 1, 2009. Essentially, the new rules are deigned to control discharges from the construction site such as sediment, turbidity, nutrients and metals. See Final Rule at 74 Fed. Reg. 62,996, 63,0003-04, 63,032 (December 1, 2009). The rule is national in scope and to the extent a state’s regulations are not as demanding the federal standard must be met. Any new construction permits after February 1, 2010 to which the act applies musts comply with the federal standard.

Thunderstorms on the Horizon for Cloud Computing

by Gibbons P.C.

Posted in E-Commerce / Licensing / Privacy and Data Security

On March 8, 2010

With the U.S. economy still reeling from the aftershock of what is now known as the “Great Recession,” companies large and small are evaluating cloud computing as a means of reducing IT costs. The National Institute of Standards and Technologies (“NIST”) and the Cloud Security Alliance have defined cloud computing as a model for on-demand network access to a shared pool of computing resources over the internet, namely software applications, data servers, networks and other services. Just as businesses and consumers now pay for gas, electricity and other utilities, cloud enthusiasts predict that the cloud will be sold on demand as a pure IT service.

The Written Description Requirements of 35 U.S.C. §112 and Ariad Pharms. Inc. v. Eli Lilly & Co.

by Gibbons P.C.

Posted in Patent / Pharmaceuticals

On February 24, 2010

Recently certain members of the patent law bar have expressed surprise that the Federal Circuit has used the written description requirements of 35 U.S.C. §112, first paragraph to invalidate patents such as the University of California’s patent directed to insulin in Regents of the University of California v. Eli Lilly & Co., and Genentech’s patent directed to production of human growth hormone in Genentech, Inc. v. Novo Nordisk A/S. This issue has come to the forefront again in Ariad’s pending per curiam appeal from the Federal Circuit decision in Ariad Pharms., Inc. v. Eli Lilly & Co., vacated and rehearing en banc granted. Oral argument in the case was held on December 7, 2009. In the case under appeal, the Ariad patent was held not to meet the written description requirements of 35 U.S.C. §112, first paragraph.

Advocacy Group Files Challenge to Governor’s COAH Executive Order

by Gibbons P.C.

Posted in Development/Redevelopment

On February 18, 2010

The Fair Share Housing Center filed a suit on February 17, 2010 challenging Governor Christie’s Executive Order halting the actions of the Council on Affordable Housing.

Biosimilars: Data Exclusivity and the “Patent Protection Gap”

by Gibbons P.C.

Posted in Biotech / Patent / Pharmaceuticals

On February 17, 2010

Several bills are currently pending in Congress establishing expedited marketing approval pathways for biosimilar drugs. The proposed pathways are analogous to the pathway for small molecule chemical drugs established by the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act includes a data exclusivity provision whereby the FDA is prohibited from approving a competitor’s drug application relying on the innovator’s data for a statutory period of time. Recent debates concerning the biosimilar bills have focused on the data exclusivity period. These debates highlight the differences between biological drugs and small molecule chemical drugs and why a longer exclusivity period may be necessary to fill the “patent protection gap.”

Duty of Disclosure: Applicant’s Contradictory Statements to EPO and USPTO Support Finding of Inequitable Conduct

by Gibbons P.C.

Posted in Patent / USPTO

On February 12, 2010

The Federal Circuit’s recent decision in Therasense, Inc. v. Becton, Dickinson & Co., No. 2008-1511 (Fed. Cir. Jan. 25, 2010) held that applicant’s statements made in proceedings before foreign patent offices may be required disclosures in prosecution before the USPTO (“PTO”), particularly when those statements directly contradict other statements made during prosecution. From the court’s holding: “An applicant’s earlier statements about prior art, especially one’s own prior art, are material to the PTO when those statements directly contradict the applicant’s position regarding that prior art in the PTO.”